Falls and Fractures among Nursing Home Residents Treated with Pimavanserin versus Other Atypical Antipsychotics: Analysis of Medicare Beneficiaries with Parkinson's Disease Psychosis.

BACKGROUND: Reducing falls and fractures remains an important clinical goal in managing older residents with Parkinson's disease psychosis (PDP) in long-term care/nursing home (LTC/NH) settings. OBJECTIVES: This analysis examined risk of all-cause falls or fractures among PDP residents on continuous monotherapy with pimavanserin (PIM) versus (i) other atypical antipsychotics (AAPs) [quetiapine (QUE), risperidone (RIS), olanzapine (OLA), aripiprazole (ARI)] and (ii) QUE. METHODS: A retrospective analysis of parts A, B, and D claims from a 100% Medicare sample (2013-2019) in LTC/NH settings was conducted. LTC/NH residents in the USA initiating continuous monotherapy (PIM versus other AAPs; PIM versus QUE) for ≥ 6 months between 01 January 2014 and 31 December 2018 were 1:1 propensity score matched (PSM) on 31 variables (age, sex, race, region, and 27 Elixhauser comorbidities). Outcomes included three measures: risks of falls only, fractures only, and falls/fractures during 6-months follow-up. Demographic characteristics were described using chi-square and t-tests. Generalized linear models were used to assess difference in risks of falls/fractures. RESULTS: Of 7187 residents, 47.59% (n = 3420) were female and mean age was 78.8 (± 7.75) years. In total, 14% (n = 1005) were on PIM and 86% (n = 6182) were on other AAPs. After PSM, falls only among PIM residents (n = 1005) was 4.58% (n = 46) versus 7.66% (n = 77) for other AAPs (n = 1005) [relative risk (RR) = 0.63 (0.46, 0.86), p < 0.05] and 8.26% (n = 83) for QUE (n = 1005) residents (p < 0.05). Fractures only among PIM residents was 1.39% (n = 14) compared with 2.09% (n = 21) for other AAPs (p = 0.31) and 1.89% (n = 19) for QUE (p = 0.49), respectively. Taken together, falls/fractures among PIM residents were 5.67% (n = 57) versus 9.05% (n = 91) for other AAPs [RR = 0.63 (0.46, 0.86), p < 0.05] and 9.55% (n = 96) for QUE (p < 0.05), respectively. CONCLUSIONS: In this analysis of LTC/NH residents with PDP, PIM had a 37% and 41% lower risk of all-cause falls/fractures versus other AAPs and versus QUE, respectively.

Healthcare resource utilization among nursing home residents with Parkinson's disease psychosis: an analysis of Medicare beneficiaries treated with pimavanserin or other-atypical antipsychotics.

Aim: Real-world healthcare resource use (HCRU) burden among patients with Parkinson's disease psychosis (PDP) treated with pimavanserin (PIM) versus other atypical antipsychotics (other-AAPs) including quetiapine (QUE) in long term care (LTC) and nursing home (NH) settings are lacking. This analysis examines HCRU differences among residents in LTC/NH settings who initiate PIM versus QUE or other-AAPs. Methods: A retrospective analysis of LTC/NH residents with PDP from the 100% Medicare claims between 1 April 2015 and 31 December 2021 was conducted. Treatment-naive residents who initiated ≥6 months continuous monotherapy with PIM or QUE or other-AAPs between 04/01/16 and 06/30/2021 were propensity score matched (PSM) 1:1 using 31 variables (age, sex, race, region and 27 Elixhauser comorbidity characteristics). Post-index (i.e., 6 months) HCRU outcomes included: proportion of residents with ≥1 all-cause inpatient (IP) hospitalizations and emergency room (ER) visits. HCRU differences were assessed via log binomial regression and reported as relative risk ratios (RR) and 95% confidence intervals after controlling for dementia, insomnia and index year. Results: From a total of PIM (n = 1827), QUE (n = 7770) or other-AAPs (n = 9557), 1:1 matched sample (n = 1827) in each cohort were selected. All-cause IP hospitalizations (PIM [29.8%]) versus QUE [36.7%]) and ER visits (PIM [47.3%] versus QUE [55.8%]), respectively, were significantly lower for PIM. PIM versus QUE cohort also had significantly lower RR for all-cause IP hospitalizations and ER visits, respectively, (IP hospitalizations RR: 0.82 [0.75. 0.9]; ER visits RR: 0.85 [0.8. 0.9]). PIM versus other-AAPs also had lower likelihood of HCRU outcomes. Conclusion: In this analysis, LTC/NH residents on PIM monotherapy (versus QUE) had a lower likelihood of all-cause hospitalizations (18%) and ER (15%) visits. In this setting, PIM also had lower likelihood of all-cause HCRU versus other-AAPs.

Analysis of Medicare Patients Treated with Pimavanserin versus Other Atypical Antipsychotics: A Cost-Offset Model Evaluating Skilled Nursing Facility Stays and Long-Term Care Admissions in Parkinson's Disease Psychosis.

Background: Patients with Parkinson's disease psychosis (PDP) treated with pimavanserin (PIM) versus other atypical antipsychotics (AAPs) including quetiapine (QUE) may have health-care cost savings due to fewer skilled nursing facility-stays (SNF-stays) and long-term care admissions (LTCA). Methods: A decision analytic model was developed using the 2019 Medicare Patient Driven Payment Model (PDPM) to estimate SNF-stays and LTCA associated per-patient- per-year (PPPY) facility and rehabilitation costs among patients that initiated PIM vs QUE or vs other-AAPs (i.e, quetiapine, risperidone, olanzapine, aripiprazole). Model inputs were derived for: (i) annual SNF-stay and LTCA rates from an analysis of Medicare beneficiaries with PDP, and (ii) annual mean rehabilitation and resident care-stay costs from PDPM case-mix adjusted value-based payment rates for 5 rehabilitation components (ie, physical-therapy, occupational-therapy, nursing, speech-language pathology, non-therapy ancillary), and an additional variable-per-diem for room/board services. PPPY costs were estimated from (i) SNF-stay and (ii) LTCA rates multiplied by annual mean costs of stay in 2022 USD. Probabilistic sensitivity analysis (PSA) was performed using 1000 Monte Carlo simulations. Results: Overall SNF-stay rates of 20.2%, 31.4%, and 31.7%, and LTCA rates of 23.2%, 33.8%, 34.6% were observed for PIM, QUE, and other-AAPs, respectively. Based on annual mean costs, PPPY SNF-stay rehabilitation and resident related costs for PIM ($41,808) vs QUE ($65,172) or vs other-AAPs ($65,664), resulted in $23,364 and $23,856 PPPY cost savings, respectively. Similarly, PPPY LTCA rehabilitation and resident related costs for PIM ($47,957) vs QUE ($70,091) or vs other-AAPs ($71,566) resulted in $22,134 and $23,609 PPPY cost-savings for PIM, respectively. PSA suggested PIM would provide cost-savings vs QUE or other-AAPs in >99% of iterations. Conclusion: In this analysis, PIM demonstrated nearly 36% and 32% lower PPPY SNF-stays and LTCA costs, respectively, vs QUE or other-AAPs. Research examining additional cost-offsets (i.e., fewer falls/fractures) associated with SNF-stay or LTCA may be needed.

Risk of long-term care admissions among Medicare beneficiaries treated with pimavanserin or quetiapine for Parkinson's disease psychosis in USA: a retrospective administrative claims database analysis.

Aim: Risk of long-term care (LTC) admission (LTCA) associated with atypical antipsychotic (AAP) use among patients with Parkinson's disease psychosis (PDP) is a major concern. However, no comparative studies have examined the differences in risk of LTC admissions between pimavanserin (PIM), the only FDA-approved AAP for PDP, and other off-label AAPs including quetiapine (QUE). Objective: To examine all-cause LTCA rates and risk among PDP patients treated with AAPs such as QUE or PIM. Methods: Analysis of Parts A, B and D claims (100% Medicare sample; 2013-2019) of Medicare beneficiaries with PDP that initiate ≥12-month continuous PIM or QUE monotherapy from 1 January 2014 to 31 December 2018 (i.e., index date) without any AAP use in the 12-month pre-index period was conducted. Outcome assessments among 1:1 propensity score-matched (31 variables - age, sex, race, region and 27 Elixhauser comorbidities) beneficiaries on PIM versus QUE included risk of all-cause skilled nursing facility stays (SNF-stays), LTC-stays, and overall LTCA (i.e., SNF-stays or LTC-stays). All-cause LTCA rates and LTCA risk were compared using logistic regression and cox proportional hazards models, respectively, controlling for demographics, comorbidities and co-existing-dementia or insomnia. Results: Of the matched sample (n = 842 for each group) from total sample (n = 9652), overall all-cause LTCA and SNF-stay rates were 23.2 and 20.2% for PIM versus 33.8 and 31.4% for QUE, respectively (p < 0.05, for each). Hazard ratio (95% CI) for risk of SNF-stay and overall LTCA was 0.78 (0.61, 0.98) and 0.80 (0.66, 0.97), respectively, for PIM versus QUE beneficiaries (p < 0.05, for each). Conclusion: The 20% lower risk of LTCA (i.e., greater delay) with PIM versus QUE in this analysis may suggest that PIM should be started early for the treatment of PDP.

Incremental health care resource utilization and costs associated among patients with Parkinson's disease psychosis and incident dementia: An analysis of medicare beneficiaries.

BACKGROUND: Real-world evidence examining the incremental health care resource use (HCRU) and cost burden of incident dementia among patients with Parkinson's disease psychosis (PDP) are needed within the United States (US). OBJECTIVES: To compare HCRU and cost burden between PDP patients with incident dementia (PDP + D) versus without incident dementia (PDP). METHODS: A retrospective analysis of inpatient (Part A), outpatient (Part B), and prescription drug (Part D) claims from the 100% Medicare sample was conducted to compare PDP + D patients versus PDP patients between 01/01/14-12/31/18. Patients with a diagnosis of dementia, psychosis, secondary parkinsonism, or other psychotic disorders, during 12-month pre-index were excluded. Patients in both groups were matched using 1:1 propensity score matching (PSM) methodology using 31 variables (age, sex, race, region and 27 Elixhauser comorbidity characteristics). Differences in 12-month post-index HCRU rates and mean per patient per year (PPPY) costs for all-cause inpatient (IP) hospitalizations, and by type of IP stay (i.e., short-term [ST-stay], skilled nursing facility [SNF-stay] and long-term [LT-stay]) were analyzed via logistic and gamma log-link regression models. RESULTS: Of the 12,484 patients who met our study criteria, 1855 PSM-matched cohorts were identified. Mean age, gender, and comorbidities were similar in PSM groups. Approximately, 50.3% with PDP + D reported ≥1 all-cause IP hospitalizations versus 36.0% with PDP (p < 0.05) during 12-month follow-up. Specifically, all-cause ST-stay, SNF-stay, and LT-stay among PDP + D versus PDP patients were: 45.2% versus 35.7%, 28.3% versus 15.7%, and 8.5% versus 6.0% (p < 0.05), respectively. Psychiatric-related ST-stay, SNF-stay, and LT-stay among PDP + D versus PDP patients were: 12.3% versus 9.0%, 7.5% versus 3.4%, and 2.4% versus 1.2% (p < 0.05), respectively. Mean PPPY all-cause IP hospitalization costs for PDP + D patients versus PDP patients was $17,891 (±29,882) versus $11,599 (±$25,247) (p < 0.05). CONCLUSIONS: Patients with PDP + D experience significantly higher all-cause and psychiatric-related IP hospitalizations, including ST-stays, LT stays, and SNF stays. They also had 54% greater mean PPPY IP hospitalization costs versus PDP patients.

Patients treated with pimavanserin or quetiapine for Parkinson's disease psychosis: analysis of health resource utilization patterns among Medicare beneficiaries.

BACKGROUND: Pimavanserin (PIM) is the only FDA approved atypical antipsychotic (AAP) for the treatment of Parkinson's Disease Psychosis (PDP) while other off-label AAPs like quetiapine (QUE) are also used. Real-world comparative effects of PIM and QUE on health resource utilization (HCRU) may provide insights about their relative benefits. OBJECTIVES: To examine annual HCRU among newly initiated PIM or QUE monotherapy among patients with PDP. METHODS: Retrospective analysis of 100% Medicare (Parts A, B, and D) claims of patients with PDP during 1 January 2013 to 31 December 2019 was conducted. Treatment-naive patients with first prescription for PIM or QUE from 1 January 2014 to 31 December 2018 were selected if they had ≥12-months continuous monotherapy and had no prior AAP use for ≥12-month pre-index. Post-index 12-month HCRU was compared between 1:1 propensity score matched (PSM) PIM or QUE cohorts. HCRU outcomes included: rates of all-cause and psychiatric-related inpatient hospitalizations by stay-type [i.e., long-term stays (LT-stays), short-term stays (ST-stays), skilled nursing facility stays (SNF-stays)], outpatient hospitalizations, emergency room (ER) visits, and office visits. Relative risk and 95% confidence intervals are reported [RR (95% CI)]. RESULTS: A total of 842 and 7,116 were treated with PIM and QUE, respectively. Mean age and gender distribution were similar among both groups. After PSM, those on PIM (n=842) had significantly lower RR for all-cause: inpatient hospitalizations [RR=0.78 (0.70-0.87)], ST-stays [RR=0.75 (0.66-0.84)], SNF-stays [RR=0.64 (0.54-0.76)], and ER visits [RR=0.91 (0.84-0.97)] vs. QUE (n=842). PIM patients had slightly higher RR for all-cause office visits [RR=1.03 (1.01-1.05)] vs. QUE. Psychiatric-related inpatient hospitalizations were also lower for PIM vs. QUE: [RR=0.63 (0.48-0.82)] ST-stays [RR=0.61 (0.43-0.86)], SNF-stay [RR=0.69 (0.47-1.02)], and ER visits [RR=0.53 (0.37-0.76)]. CONCLUSIONS: In this analysis of PDP patients, PIM monotherapy resulted in nearly 22% and 37% lower all-cause hospitalizations and psychiatric-related inpatient hospitalizations compared to QUE.

A targeted literature review of health economic analyses of human papillomavirus vaccination from various countries.

BACKGROUND: Understanding the cost-effectiveness of the HPV vaccine from a global perspective is important to assess from a policy perspective and to support current and future HPV vaccination programs. OBJECTIVES: The aim of this analysis was to conduct a targeted literature review of published pharmacoeconomic literature on the cost-effectiveness of the HPV vaccine to treat patients in various countries, with a focus on cost-savings and their impact on vaccine recommendations. METHODS: We searched cost-effectiveness studies in HPV published in peer-reviewed literature from 2012 to 2020 using MEDLINE via the PubMed database and Google Scholar. RESULTS: HPV vaccine cost-effectiveness was found to be greatest in low-income countries where screen programs were not yet in place, additionally, in adolescent males and females. The majority of the economic evaluations viewed the implementation of the HPV vaccine as cost-effective and recommended national HPV vaccination. CONCLUSION: The majority of economic studies favored national HPV vaccination for adolescent males and females in various countries. Feasibility of this strategy and implementation remains an open question, in addition to screening coverage rate in countries with no vaccine programs or countries yet to introduce national HPV vaccination.

Burden of Illness Among Patients with Psychosis due to Dementia with Lewy Bodies and Other Dementias.

Limited research is available on the real-world experiences of patients with dementia with Lewy bodies (DLB). This study evaluated clinical events, healthcare utilization, and healthcare costs of patients with DLB vs other dementia types with psychosis (ODP). Study patients included commercial and Medicare Advantage with Part D enrollees aged ≥40 years with evidence of DLB and ODP from 6/01/2015‒5/31/2019. Compared with patients with ODP, more patients with DLB had clinical events including anticholinergic effects, neurologic effects, and cognitive decline. Patients with DLB used more healthcare resources with greater dementia-related office and outpatient visits and psychosis-related inpatient stays and office, outpatient, and emergency visits compared with their ODP patient counterparts. Patients with DLB also incurred higher healthcare costs for all-cause and dementia-related office visits and pharmacy fills, and psychosis-related total costs. Understanding the clinical and economic impact of DLB and ODP is important to improve care for patients with dementia.

Comparative Efficacy, Safety, and Acceptability of Pimavanserin and Other Atypical Antipsychotics for Parkinson's Disease Psychosis: Systematic Review and Network Meta-Analysis.

BACKGROUND: The current comparative efficacy, safety, and acceptability of atypical antipsychotics (AAPs) in treating Parkinson's Disease Psychosis (PDP) are not entirely understood. OBJECTIVE: To evaluate comparative efficacy, safety, and acceptability of AAPs in patients with PDP. METHODS: We conducted a systematic review and a network meta-analysis to compare the efficacy, safety, and acceptability of pimavanserin, quetiapine, olanzapine, clozapine, ziprasidone, and risperidone. We estimated relative standardized mean differences (SMDs) for continuous outcomes and odds ratios (OR) for binary outcomes, with their respective 95% confidence intervals (CIs). RESULTS: We included 19 unique studies evaluating AAPs in a total of 1,242 persons with PDP. Based on Clinical Global Impression Scale for Severity, pimavanserin (SMD, -4.81; 95% CI, -5.39, -4.24) and clozapine (SMD, -4.25; 95% CI, -5.24, -3.26) significantly improved symptoms compared with placebo. Also, compared to placebo, pimavanserin (OR, 1.16; 95% CI, 1.07, 1.24) significantly improved psychotic symptoms based on Scale for Assessment of Positive Symptoms for Parkinson's Disease Psychosis/Hallucinations and Delusions scores. In comparison to placebo, clozapine (SMD, -0.69; 95% CI, -1.35, -0.02), pimavanserin (SMD, -0.01; 95% CI, -0.56, 0.53), and quetiapine (SMD, 0.00; 95% CI, -0.68, 0.69) did not impair motor function per Unified Parkinson's Disease Rating scale. Based on Mini-Mental State Examination scale, quetiapine (SMD, 0.60; 95% CI, 0.07, 1.14) significantly impaired cognition compared to placebo. CONCLUSIONS: In patients with PDP, pimavanserin and clozapine demonstrated significant improvement in psychosis without affecting motor function. With quetiapine being associated with a significant decline in cognition and despite not impairing motor function, our findings suggest that it should be avoided in patients with PDP and reduced cognitive abilities.

Health care resource utilization patterns among patients with Parkinson's disease psychosis: analysis of Medicare beneficiaries treated with pimavanserin or other-atypical antipsychotics.

BACKGROUND: Pimavanserin (PIM) is the only FDA-approved atypical antipsychotic (AAP) for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Comparative real-world analyses demonstrating its benefits are needed. OBJECTIVES: To evaluate health care resource utilization (HCRU) outcomes among PDP patients treated with PIM vs. other-AAPs. METHODS: Retrospective cohort analysis of Parts A, B, and D claims from 100% Medicare sample from 01 January 2013-31 December 2019 was conducted. PDP Patients initiating (i.e. index date) continuous monotherapy (PIM vs. other-AAPs) for ≥12-months during 01 January 2014-31 December 2018 without 12-months pre-index AAP use were selected after 1:1 propensity score matching (PSM) on 31 variables (sex, race, region, age, and 27 Elixhauser comorbidities). HCRU outcomes included: annual all-cause and psychiatric hospitalization (short-term stay, long-term stay, and SNF-stay [skilled nursing facility]) rates, annual all-cause and psychiatric-ER visit rates, mean per-patient-per-year (PPPY) hospitalizations, and average length of stay (ALOS). PIM and other-AAPs were compared using generalized linear models (GLM) controlled for demographic characteristics, comorbidities, coexisting-dementia, and coexisting insomnia. RESULTS: Of 12,164 PDP patients, 48.41% (n = 5,889) were female, and mean age was 77 (±8.14) years. Among 1:1 matched patients (n = 842 in each), 37.8% (n = 319) on PIM vs. 49.8% (n = 420) on other-AAPs (p < .05) reported ≥1 all-cause hospitalizations, respectively. Specifically, short-term and SNF-stay among PIM patients vs. other-AAPs were: 34% (n = 286) vs. 46.2% (n = 389) and 20.2% (n = 170) vs. 31.8% (n = 267) (p < .05), respectively. Similarly, 9.6% (n = 81) of PIM vs. 14.6% (n = 123) of other-AAPs patients had ≥1 psychiatric hospitalization (p < .05). Furthermore, ≥1 all-cause and psychiatric ER visit among PIM vs. other-AAPs were 61.6% (n = 519) vs. 69.4% (n = 584) and 5.2% (n = 43) vs. 10.2% (n = 86) (p < .05), respectively. PIM also had significantly lower ALOS, and mean PPPY short-term hospitalization and SNF-stays. CONCLUSIONS: In this analysis of PDP patients, PIM monotherapy resulted in nearly 12% and 7% lower all-cause hospitalizations and ER visits vs. other-AAPs.